Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K150818
Device Name Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact PATRICK MCCULLAGH
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact STEPHEN H MCKELVEY
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
HRS  
Date Received03/27/2015
Decision Date 05/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-